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Recruiting NCT06605989

Nostril Side on Epistaxis

No phase Interventional Nasotracheal Intubation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nasotracheal intubation.
Who it may be relevant to
Registry conditions: Nasotracheal Intubation. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Nostril Side on Epistaxis During Nasotracheal Intubation

Overview

The purpose of the study is to investigate the effect of the nostril side on epistaxis during nasotracheal intubation.

Detailed description

This prospective randomized controlled study was approved by the IRB of our institute.

Patients requiring nasotracheal intubation will be screened for eligibility for the study. Then, patients will be randomized to one of two groups; (Group I: tube will be inserted through the left nostril and advanced into the oral cavity / Group II: tube will be inserted through the right nostril and advanced into the oral cavity). After induction of anesthesia and muscle relaxation, the preformed nasal RAE (Ring-Adair-Elwyn) tube will be inserted via the nostril, which is assigned to each patient according to the group, approximately 3-4 cm. Next, an anesthesiologist will advance the tube into the oral cavity. After the tube is placed in the oral cavity, the anesthesiologist will perform nasotracheal intubation with Magill forceps. After that, an investigator will check the occurrence of epistaxis due to nasotracheal intubation and its severity with a fiberoptic bronchoscope. After obtaining all data, investigators will analyze the incidence of epistaxis and its severity between the two groups.

Interventions

  • Procedure Nasotracheal intubation
    For nasotracheal intubation, the nasal RAE tube will be first inserted through the left nostril for patients in the left nostril side arm. For nasotracheal intubation, the nasal RAE tube will be first inserted through the right nostril for patients in the right nostril side arm.

Primary outcome measures

  • epistaxis [Time frame: during nasotracheal intubation]

Eligibility criteria

Inclusion criteria

  • adult patients requiring nasotracheal intubation for elective surgery

Exclusion criteria

  • refuse to participate in the study
  • severe deformity in the nose
  • current severe epistaxis
  • cannot insert the tube into a specific nostril side due to any reason

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

South Korea · 2 centers
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center — Seoul
  • Gangnam Severance Hospital — Seoul

Publications

  • Sanuki T, Hirokane M, Kotani J. Epistaxis during nasotracheal intubation: a comparison of nostril sides. J Oral Maxillofac Surg. 2010 Mar;68(3):618-21. doi: 10.1016/j.joms.2009.04.097. Epub 2009 Nov 22. PMID 19931965

Identifiers

NCT: NCT06605989 · 04-2024-0025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗